Translingual Neurostimulation for the Virtual Treatment of Post-Traumatic Stress Disorder: A Feasibility Pilot
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Proportion of participants screened who are eligible
研究概览
简要总结
A growing body of evidence suggests that translingual neurostimulation (TLNS) plays a role in modulating neuroplastic changes in the brain, which has far-reaching implications for its ability to facilitate other therapeutic interventions such as cognitive processing therapy (CPT) for post-traumatic stress disorder (PTSD). The present study aims to assess the feasibility of combining TLNS with CPT in individuals with PTSD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, at least 19 years of age or older
- •A score of 33 or more on the Posttraumatic Stress Disorder Checklist (PCL-5)
- •PTSD symptom duration of ≥ 12 months
- •Stable dose of any medications for the last three months, with no changes anticipated for the duration of the study
- •Adequate support at home (e.g., family member or caregiver) to ensure assistance in seeking access to help if needed
- •Able to understand the informed consent form, study procedures and willing to participate in study
- •Currently has a primary care provider
排除标准
- •History of substance dependence or abuse (within the last 3 months)
- •Unstable psychosocial settings (homelessness, lack of support at home)
- •Moderate to high risk of suicidal ideation or behaviour as measured by the Columbia Suicide Severity Rating Scale (C-SSRS)
- •Current diagnosis of severe anxiety (or score of ≥15 on the GAD-7), severe depression (or score of ≥20 on the PHQ-9), schizophrenia or bipolar disorder
- •Use of medications for PTSD within the last 6 weeks
- •History of other major neurological disorder (brain cancer, dementia, multiple sclerosis, stroke)
- •Detection of mild cognitive impairment (mini-ACE score of ≤ 25)
- •Diagnosed epilepsy or history of seizures
- •Not proficient in English
- •Recent (within last 2 years) acquired brain injury
- •Exposed to an investigational drug or device 30 days prior to starting the study, or concurrent use of an investigational drug or device while enrolled in the study
- •If female and of child-bearing potential: pregnant, suspected or planning to become pregnant or breast-feeding
- •Contraindicated for the NeuroCatchTM Platform, including:
- •Requires the use of hearing aids or a cochlear implant 13.
- •Diagnosed with tinnitus that is currently active 13.
- •Has temporary damage to earing (e.g. punctured ear drum) 13.
- •Unable to detect a 740Hz tone played at 85dB in both ears. 13.
- •Implanted pacemaker or implanted electrical stimulators 13.
- •Metal or plastic implants in the skull, excluding dental/facial implants 13.
- •Unhealthy scalp (apparent open wounds and/or bruised or weakened skin) 13.
- •Previous exposure to the NeuroCatch™ Platform audio sequences in the last 3 months
- •Contraindicated for PoNSTM use, including:
- •Current disease or sensitivity of the oral cavity 14.
- •History of oral cancer 14.
- •Oral surgery within three months of screening 14.
- •Oral cavity piercings that could interfere with PoNSTM use 14.
- •Sensitivity to Nickel, Copper, or Gold 14.
- •Currently enrolled in a PoNSTM treatment program or use of the PoNSTM device in the last 5 weeks 14.
- •History of penetrating brain injuries 14.
- •History of neurodegenerative diseases 14.
- •Chronic infectious disease 14.
- •Unmanaged hypertension 14.
- •Diabetes 14.
- •History of seizures
结局指标
主要结局
Proportion of participants screened who are eligible
时间窗: Baseline to week 6
Reach (RE-AIM framework)
Ease of protocol administration
时间窗: Baseline to week 6
Adoption (RE-AIM framework); 5-point Likert scale for participants and therapists
Clinician-rated symptom severity as measured by CAPS
时间窗: Change from baseline to week 6
Effectiveness (RE-AIM framework)
Qualitative report of barriers and facilitators
时间窗: Baseline to week 6
Implementation (RE-AIM framework)
Participant rated symptom severity as measured by the PCL-5
时间窗: Change from baseline to week 6
Effectiveness (RE-AIM framework)
Proportion of therapy visits completed
时间窗: Baseline to Week 6
Adoption (RE-AIM framework)
次要结局
- Generalized Anxiety Disorder 7-item (GAD-7)(Change from baseline to week 6)
- Time from inciting event(Baseline)
- Patient Health Questionnaire (PHQ-9)(Change from baseline to week 6)
- Brief Inventory of Psychosocial Functioning (B-IPF)(Change from baseline to week 6)
- Meaning in Life Questionnaire (MLQ)(Change from baseline to week 6)
- Electroencephalography (EEG)(Change from baseline to week 6)